FDA 510(k) Application Details - K142174

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K142174
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. 1F., NO.59, LUKE 2ND RD., LUZHU TOWNSHIP KAOHSIUNG COUNTY 820 TW Other 510(k) Applications for this Company
Contact	WAYNE CHEN Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2014
Decision Date	03/20/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review